← Back to Search

Immunotherapy

Haplo-Cord Transplantation for Blood Cancer

Phase 2
Waitlist Available
Led By Koen van Besien, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have a confirmed diagnosis of chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after transplant
Awards & highlights

Study Summary

This trial is testing whether it's more important to identify a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted or the nucleated cell dose when doing a haplo cord transplant.

Who is the study for?
This trial is for adults over 18 with various blood cancers or disorders needing a transplant, like leukemia, lymphoma, myeloma, and more. They should be in good enough health to tolerate the procedure (KPS >= 70%) and have acceptable organ function. It's not suitable for those who can find an exact donor match quickly, are pregnant or breastfeeding, have severe heart/lung problems, active hepatitis/cirrhosis, uncontrolled infections or HIV.Check my eligibility
What is being tested?
The study tests whether matching a cord blood graft to inherited paternal antigens (IPAs) improves haplo-cord transplant outcomes compared to just focusing on cell dose. Participants receive stem cells from both umbilical cord blood and a half-matched family donor after chemotherapy conditioning but no experimental drugs are used.See study design
What are the potential side effects?
Potential side effects include reactions related to immune suppression such as infection risk increase due to medications like anti-thymocyte globulin and Tacrolimus; chemotherapy-related nausea; fatigue; mouth sores from Fludarabine/Melphalan; infusion reactions from Rituximab; and complications from Total Body Irradiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic myelogenous leukemia in a specific phase.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with recurrent or refractory lymphoma.
Select...
I have been diagnosed with myelodysplastic syndrome.
Select...
I have been diagnosed with multiple myeloma.
Select...
I have been diagnosed with a chronic blood disease.
Select...
I have been diagnosed with a blood disorder affecting my hemoglobin.
Select...
I have been diagnosed with aplastic anemia.
Select...
I have a blood disorder requiring a stem cell transplant.
Select...
My leukemia has returned or didn't respond to treatment.
Select...
My acute leukemia is in its first remission and is at high risk of coming back.
Select...
I have chronic lymphocytic leukemia that has come back or is hard to treat.
Select...
I don't have a matching donor available quickly.
Select...
My liver and kidney functions are within the required range.
Select...
I am mostly able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lowest threshold of umbilical cord nucleated cell dose for haplo-cord transplants.
Secondary outcome measures
Transplantation
Impact of NIMA matching on transplant outcome
Transplantation

Trial Design

1Treatment groups
Experimental Treatment
Group I: All PatientsExperimental Treatment8 Interventions
Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1090
Melphalan
2008
Completed Phase 3
~1500
Rituximab
1999
Completed Phase 4
~1880
Total Body Irradiation
2006
Completed Phase 3
~820
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,599 Total Patients Enrolled
Koen van Besien, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
67 Total Patients Enrolled
Alexandra Gomez Arteaga, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Anti-thymocyte globulin (rabbit) (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01810588 — Phase 2
Blood Cancers Research Study Groups: All Patients
Blood Cancers Clinical Trial 2023: Anti-thymocyte globulin (rabbit) Highlights & Side Effects. Trial Name: NCT01810588 — Phase 2
Anti-thymocyte globulin (rabbit) (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01810588 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have agreed to join this clinical experiment?

"Affirmative. The clinicaltrials.gov website shows that this medical study is open for enrollment, having first been posted on October 16th 2012 and most recently updated on September 20th 2022. 500 participants will be recruited from two distinct research centers."

Answered by AI

What conditions can Total Body Irradiation be utilized to address?

"Total Body Irradiation is regularly used in immunosuppressive treatments. This modality has also been deployed to address dermatitis, atopic conditions, b-cell lymphomas and polyangium."

Answered by AI

What is the regulatory status of Total Body Irradiation?

"There is limited clinical evidence for the safety of Total Body Irradiation, thus it has been given an assessment score of 2. Since this is a Phase Two trial, there are no efficacy results available yet."

Answered by AI

Has Total Body Irradiation been the subject of additional research efforts?

"The year 1993 marked the initial research into Total Body Irradiation at National Institutes of Health Clinical Center, 9000 Rockville Pike. To date, 1897 clinical trials on this topic have been completed and an additional 945 are currently underway; many of these studies being executed in Chicago, Illinois."

Answered by AI

Is there presently an opportunity for participants to join this clinical trial?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial is actively looking for patients with the original listing having been posted on October 16th 2012 and updated recently on September 20th 2022. 500 individuals need to be enrolled from two different locations."

Answered by AI
~22 spots leftby Mar 2025